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    The EU Clinical Trials Register currently displays   41470   clinical trials with a EudraCT protocol, of which   6815   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004129-27
    Sponsor's Protocol Code Number:X06-MMRV-302
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-10-05
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2006-004129-27
    A.3Full title of the trial
    An open, randomised, comparative, multicentre study of the immunogenicity and safety of concomitant versus separate administration of a combined measles, mumps, rubella and varicella live vaccine (ProQuad®) and a booster dose of Infanrix® hexa in healthy children 12 to 23 months of age.
    A.4.1Sponsor's protocol code numberX06-MMRV-302
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorSanofi Pasteur MSD
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name PROQUAD
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePROQUAD
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMeasles virus Enders'Edmonston Strain (live, attenuated)
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.00 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMumps virus Jeryl lynn (level B) strain (live, attenuated)
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number4.30 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRubella virus Wistar RA 27/3 strain (live, attenuated)
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.00 log10 CCID50
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVaricella virus Oka/Merck strain (live, attenuated)
    D.3.10 Strength
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number3.99 log10 PFU
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Infanrix hexa
    D.2.1.1.2Name of the Marketing Authorisation holderGlaxosmithkline Biologicals s.a.
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameInfanrix hexa
    D.3.4Pharmaceutical form Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDiphtheria toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number30
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTetanus toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typenot less then
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertussis toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFilamentous Haemagglutinin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPertactin
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHepatitis B surface antigen
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInactivated Type 1 Poliovirus (Mahoney)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40 D-antigen unit
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInactivated Type 2 poliovirus (MEF-1)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number8 D-antigen unit
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInactivated Type 3 poliovirus (Saukett)
    D.3.10 Strength
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number32 D-antigen unit
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNHaemophilus influenzae type b polysaccharide conjugated to 20-40 micrograms of tetanus toxoid
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    The study will involve healthy children.
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate that ProQuad® can be administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age without impairing neither the antibody response rates to measles, mumps, rubella, varicella, hepatitis B and Haemophilus influenzae type b, nor the 3 pertussis antibody titres as measured at 42 days following vaccination.
    E.2.2Secondary objectives of the trial
    To describe the antibody titres and the antibody response rates to measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b as measured at 42 days following vaccination when administered to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled.

    To evaluate the safety profile of ProQuad® when administered concomitantly with a booster dose of Infanrix® hexa to healthy children 12 to 23 months of age, by Infanrix® hexa primary series schedule and for all data pooled.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Healthy subject of either gender,
    2. Age from 12 to 23 months [from the 12th month birthday to 1 day prior to the 24th month birthday],
    3. Negative clinical history of measles, mumps, rubella, varicella and zoster,
    4. For Italy: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 2-dose schedule, with receipt of the second dose ≥ 6 months prior to inclusion,
    For Germany: Primary vaccination with the combined diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b vaccine Infanrix® hexa as a 3-dose schedule, with receipt of the third dose ≥ 6 months prior to inclusion,
    5. Consent form signed by parent(s) according to local regulations or by the legal representative properly informed about the study,
    6. Parent(s) / legal representative able to understand the protocol requirements and to fill in the Diary Card.
    E.4Principal exclusion criteria
    1. Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
    2. Any recent (<or=30 days) exposure to measles, mumps, rubella, varicella and/or zoster involving:
    a. continuous household contact, or
    b. playmate contact (generally >1 hour of play indoors), or
    c. hospital contact (in same 2- to 4-bed room or adjacent beds in a large ward or face-to-face contact with an infectious staff member or subject), or
    d. in the case of varicella, contact with a newborn whose mother had onset of varicella 5 days or less before delivery or within 48 hours after delivery,
    3. Receipt of any other diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenzae type b containing vaccine (either alone or in any combination) than Infanrix® hexa,
    4. Any recent (<or= 3 days) history of febrile illness (rectal temperature >or= 38.0°C),
    5. Any severe chronic disease,
    6. Active untreated tuberculosis,
    7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
    8. Any known blood dyscrasia, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic or lymphatic systems,
    9. Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
    10. Prior known sensitivity/allergy to any component of the vaccines including neomycin, sorbitol or gelatin,
    11. Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (>or= 14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (>or= 2 mg/kg/day prednisone equivalent or >or= 20 mg/day if weight more than 10kg) within the previous 30 days] or other immunosuppressive therapy,
    12. Any recent (<or= 2 days) tuberculin test or scheduled tuberculin test through Visit 2,
    13. Any previous (<or= 150 days) receipt of immune serum globulin or any blood-derived products or scheduled to be administered through Visit 2,
    14. Any recent (<or= 30 days) receipt of an inactivated or a live non-study vaccine or scheduled non-study vaccination through Visit 2,
    15. Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives,
    16. Any recent (<or= 30 days) participation or scheduled participation in any other clinical trial through Visit 2.
    E.5 End points
    E.5.1Primary end point(s)
    The primary immunogenicity criteria are the response rates to measles, mumps, rubella and varicella in Group 1 and Group 2 and to hepatitis B and Haemophilus influenzae type b in Group 1 and Group 3 and the antibody titres to the 3 pertussis antigens in Group 1 and Group 3 as follows:
    • The response rate for measles defined as the percentage of subjects with measles antibody titres ³ 255 mIU/mL in subjects whose baseline (BS1) measles antibody titre is < 255 mIU/mL,
    • The response rate for mumps defined as the percentage of subjects with mumps antibody titres ³ 10 ELISA Ab units/mL in subjects whose baseline (BS1) mumps antibody titre is < 10 ELISA Ab units/mL,
    • The response rate for rubella defined as the percentage of subjects with rubella antibody titres ³ 10 IU/mL in subjects whose baseline (BS1) rubella antibody titre is < 10 IU/mL,
    • The response rate for varicella defined as the percentage of subjects with varicella antibody titres ³ 5 gpELISA units/mL in subjects whose baseline (BS1) varicella antibody titre is < 1.25 gpELISA units/mL,
    • The response rate for hepatitis B defined as the percentage of subjects with antibody titres (anti-HBs) ³ 10 mIU/mL,
    • The response rate for Haemophilus influenzae type b defined as the percentage of subjects with antibody titres (anti-PRP) ³ 1.0 μg/mL.
    • The post-vaccination GMT to pertussis (anti-PT, anti-FHA and anti-PRN),
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Immunogenicity and safety of concomitant versus separate administration of Proquad and Infanrix hexa
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned50
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA60
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial will be the last visit of the last subject.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state960
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 960
    F.4.2.2In the whole clinical trial 960
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-12-13
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-03-27
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